Development and Feasibility of CTraC-FIT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-01

Study Completion Date

2030-12-31

Brief Summary

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Functional decline after hospitalization is a serious concern for older Veterans, often leading to loss of independence and disability. VA's nurse-led Coordinated Transitional Care (CTraC) program has demonstrated success in improving care transitions, but currently lacks targeted assessment and intervention to support Veterans' functional recovery. This project aims to develop and test a function-focused CTraC protocol (CTraC-FIT) to address this critical gap and optimize functional outcomes for Veterans transitioning from hospital to home. By integrating evidence-based functional assessment and intervention strategies into the CTraC protocol, this project aims to empower Veterans to regain and maintain their independence and improve their quality of life.

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Detailed Description

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Nearly two-thirds of older adults experience significant functional decline after hospital discharge, resulting in loss of independence, institutionalization, and even death. Functional decline (i.e., loss of physical or cognitive ability that makes it difficult or impossible to perform activities of daily living) often occurs after hospital discharge due to a complex interplay between pre-existing health conditions, physiological stressors, and reduced mobility and activity levels during hospitalization. Veterans are at particular risk of functional decline as they experience a disproportionate burden of physical and psychological conditions compared to their non-Veteran peers. Transitions from hospital to home serve as critical junctures to address Veterans' functional needs, but many patients are discharged without a comprehensive functional evaluation. Even when evaluation occurs, discharge plans often fail to translate into effective care delivery, creating a concerning gap between planned and actual support after hospitalization.

The Coordinated Transitional Care (CTraC) program is a potential foundation on which to build a protocol that meets Veterans' rehabilitative care needs during and after discharge. CTraC is a nurse-led transitional care program developed to improve Veterans' transitions to the community after hospitalization. CTraC aims to address key components of transitional care: (1) care planning and communication; (2) medical follow-up; (3) education on symptom management; and (4) medication safety/management. In this model, the CTraC nurse identifies and meets Veterans at high risk of readmission, helps optimize their discharge planning, and then delivers a protocolized phone-based intervention for up to 30 days. CTraC has demonstrated significant benefits to VA, including a 50% reduction in readmissions, resolution of medication discrepancies for more than half of enrolled patients, and cost savings. Yet, the existing CTraC protocol misses a critical opportunity to include functional assessment and intervention to support Veterans' functional recovery.

The goal of this CDA-2 proposal is to develop and test a function-focused protocol for VA's CTraC program. The aim is to leverage CTraC's established success and infrastructure to comprehensively address Veterans' rehabilitation needs after hospitalization and optimize their functional recovery and independence during the transition from hospital to home. Specifically, this project aims to:

Aim 1: Develop \& refine CTraC-FIT (Functional Independence aT home) for Veterans at risk of functional decline transitioning from hospital to home. (1a) Develop CTraC-FIT to support Veterans' functional recovery based on input from clinicians (n=15) across hospital and outpatient settings (e.g., CTraC NCMs, inpatient providers, primary care providers, physical therapists, and occupational therapists). (1b) Conduct a nonrandomized, preliminary pilot of the CTraC-FIT intervention (n=5 Veterans) and collect qualitative feedback from Veterans and the CTraC NCM to refine the intervention protocol and study procedures, as well as address any unanticipated barriers before pilot testing.

Aim 2: Examine the feasibility and acceptability of CTraC-FIT in a pilot randomized controlled trial via randomization of n=40 Veterans to either CTraC-FIT (n=20) or an enhanced usual care condition (n=20). The primary outcomes will be feasibility and acceptability of the intervention protocol and study procedures. Feasibility and acceptability of the intervention protocol will be measured via survey and qualitative interviews with Veterans, and surveys with clinicians (n\~20). Feasibility of the study procedures will be assessed via data logs (e.g., recruitment, enrollment, retention, adherence, randomization, and fidelity). Secondary outcomes will include Veterans' self-reported quality of life, social and cognitive function as well as self-reported and performance-based physical function measured at baseline, post-intervention, and 3-months post-intervention.\]

Conditions

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Functional Impairment Functional Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators will conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility, acceptability, and preliminary effects of the CTraC-FIT protocol. Participants will be randomized into two groups: CTraC-FIT intervention and control group receiving enhanced usual care (EUC).

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Given the nature of the intervention, it is not feasible to use double blinding where both participants and assessors are unaware of group assignments. Instead, a single-blind design will be employed where the participants are not aware of their specific group assignments.

Study Groups

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CTraC-FIT

The intervention arm involves participants receiving a structured transitional care intervention (CTraC-FIT) administered by a trained nurse case manager via phone or VA Video Connect, aimed at improving functional abilities and reducing hospital readmissions.

Group Type EXPERIMENTAL

CTraC-FIT

Intervention Type OTHER

The intervention is designed to support Veterans at high risk of readmission with comprehensive transitional care that includes:

Structured Follow-Ups: Regularly scheduled follow-up calls to monitor the patient's progress, address any issues, and provide ongoing support.

Health Coaching: Personalized coaching to help Veterans manage their health conditions, adhere to treatment plans, and make lifestyle changes that can improve their overall health.

Care Coordination: Assistance with navigating the healthcare system, facilitating appointments, and ensuring that the Veteran receives all necessary post-discharge services.

The intervention arm aims to improve functional abilities and reduce hospital readmissions by providing tailored support based on the unique needs of each participant. The CTraC NCM will follow a standardized protocol to ensure consistent and effective delivery of the intervention across all participants in this group.

Enhanced Usual Care

The Enhanced Usual Care (EUC) arm involves participants receiving the standard care provided by their assigned Veterans Affairs Boston Healthcare System (VABHS) inpatient and outpatient teams.

Group Type OTHER

Enhanced Usual Care

Intervention Type OTHER

The Enhanced Usual Care (EUC) arm involves participants receiving the standard care provided by their assigned Veterans Affairs Boston Healthcare System (VABHS) inpatient and outpatient teams. This includes routine medical evaluations, treatments, and follow-up appointments as typically recommended by their healthcare providers. In addition to receiving standard care, participants in the EUC group will undergo baseline, endpoint, and 3-month follow-up assessments as part of the study protocol.

For participants with intermediate functional ability (SPPB score of 7-9), no additional intervention will be provided after randomization to the control group. However, for participants with low functional ability (SPPB score of 0-6), a safety protocol will be activated to notify their assigned inpatient medical team (e.g., hospitalist, social worker) about the participant's risk of functional decline, ensuring that appropriate support and referrals are provided if needed.

Interventions

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CTraC-FIT

The intervention is designed to support Veterans at high risk of readmission with comprehensive transitional care that includes:

Structured Follow-Ups: Regularly scheduled follow-up calls to monitor the patient's progress, address any issues, and provide ongoing support.

Health Coaching: Personalized coaching to help Veterans manage their health conditions, adhere to treatment plans, and make lifestyle changes that can improve their overall health.

Care Coordination: Assistance with navigating the healthcare system, facilitating appointments, and ensuring that the Veteran receives all necessary post-discharge services.

The intervention arm aims to improve functional abilities and reduce hospital readmissions by providing tailored support based on the unique needs of each participant. The CTraC NCM will follow a standardized protocol to ensure consistent and effective delivery of the intervention across all participants in this group.

Intervention Type OTHER

Enhanced Usual Care

The Enhanced Usual Care (EUC) arm involves participants receiving the standard care provided by their assigned Veterans Affairs Boston Healthcare System (VABHS) inpatient and outpatient teams. This includes routine medical evaluations, treatments, and follow-up appointments as typically recommended by their healthcare providers. In addition to receiving standard care, participants in the EUC group will undergo baseline, endpoint, and 3-month follow-up assessments as part of the study protocol.

For participants with intermediate functional ability (SPPB score of 7-9), no additional intervention will be provided after randomization to the control group. However, for participants with low functional ability (SPPB score of 0-6), a safety protocol will be activated to notify their assigned inpatient medical team (e.g., hospitalist, social worker) about the participant's risk of functional decline, ensuring that appropriate support and referrals are provided if needed.

Intervention Type OTHER

Other Intervention Names

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Coordinated Transitional Care EUC

Eligibility Criteria

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Inclusion Criteria

* .Age \> or = 65 years
* Score of \> 3 on Vulnerable Elders Survey, (VES-13)
* Score of 4-9 on Short Physical Performance Battery (SPPB)
* Able to provide informed consent

Exclusion Criteria

* Admitted to VA Boston for acute psychiatric are or substance abuse detoxification
* Plan to discharge anywhere except home (e.g., assisted living, group home, or skilled nursing facility)

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No